Abstract

While the regulation of healthcare in EU member states has remained largely unaffected by EU influence, the opposite is true for the regulation of pharmaceutical safety. Since the thalidomide crisis, supranational influence has constantly and continuously expanded in this regulatory field. The emergence of European pharmaceutical policy raises two main questions adressed in the present study. The first question relates to the delegation of regulatory competencies in the pharmaceutical sector. Pharmaceuticals are important for the maintenance of public health but at the same time represent a consumption risk. Therefore, the need for public intervention arises. Governments play an important role in the financing of pharmaceuticals and the protection of their citizens from potentially harmful products. The protection of its citizens is one of the key tasks of the state. The evident delegation of regulatory powers to the European level in the field of risk regulation thus seems to be at odds with the member states’ need to legitimize their activities. The present study thus tries to develop an explanation for the delegation of regulatory competencies in the area of pharmaceutical regulation and in the field of risk regulation in more general terms. The second part of the study analyses in how far the Europeanization of pharmaceutical regulation has impacted on the quality of regulation and its effectiveness, depicting the degree of regulatory goal attainment. The study covers the development of pharmaceutical regulation from the late 1950s until the end of 2008.